Dr. Kasturi Rao

Dr. Kasturi Rao holds a Doctor of Philosophy (Ph.D.) degree in Cancer Research and a Masters degree in Molecular Biology and Human Genetics.

She has 13 years of experience in the Life Sciences Industry, including 5 years of experience in Regulatory Writing for Medical Devices. She has authored and reviewed various critical documents such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) documentation, Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) documents for medical devices. These documents adhere to EU Medical Device Regulation (MDR) and MEDDEV 2.7/1 Rev 4 guidelines, ensuring compliance and quality.

At Celegence, she leads a team specializing in creating various regulatory documents for different therapeutic areas which include Dentistry, GI -Surgical devices, Nasal and Voice Prothsesis, Implants, etc to name a few.​ Kasturi and team have also successfully addressed feedback from Notified Bodies like BSI, DEKRA, and achieved MDR certification for new and MDD certified devices. She has also been a panellist on webinars in association with MTI and Q1 Productions, on topics related to Clinical Evaluation.